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(Reuters) – The Food and Drug Administration said it has formed a partnership with the medical device industry aimed at speeding the development and review of new device products. The nonprofit organization, called the Medical Device Innovation Consortium, will collaborate with patient support groups, academia, foundations and the Centers for Medicare and Medicaid Services to improve the process for bringing medical devices into the marketplace. …
(Reuters) – Creating new rules for food safety is too complex a task to be completed quickly and a lawsuit seeking to compel government action should be dismissed, according to the U.S. Food and Drug Administration. The FDA said that although it was behind schedule in modernizing food safety regulations as set out in a law signed in January 2011, the agency's broad role in regulating a $450 billion domestic and imported food business requires additional time. "The enormity and scope of the task given to FDA cannot be overstated," the FDA said in a motion filed Friday in U.S. …
WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Thursday approved Exelixis Inc’s cabozantinib as a treatment for medullary thyroid cancer that has spread to other parts of the body. Cabozantinib, the company’s lead product candidate, is an oral drug designed to limit blood supply to tumors as well as block two segments of a pathway used by cancer cells to grow and spread. The FDA announcement came shortly after the close of stock market trading in New York, where Exelixis shares eased slightly on the day at $5.24 per share. …
(Reuters) – Indian generic drugmaker Ranbaxy Laboratories will stop manufacturing its version of Pfizer Inc’s cholesterol fighter, Lipitor, while it gets to the bottom of the cause of a recent recall, the U.S. Food and Drug Administration said on its website. Earlier this month, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg after the company discovered contamination with tiny glass particles. …
(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Wednesday voted that an experimental Johnson & Johnson drug for multidrug-resistant tuberculosis appears to be safe and effective, but highlighted potential heart and liver-safety issues. The medicine, called bedaquiline, targets adenosine triphosphate synthase, an enzyme the tuberculosis bacterium needs to generate its energy. If approved, J&J said it would be the first drug in 40 years with a new mechanism of action against tuberculosis. …
(Reuters) – The U.S. Food and Drug Administration suspended operations on Monday at a New Mexico food producer linked to salmonella-tainted peanut butter that has sickened at least 41 people this year, the agency said in a statement. The FDA said it had suspended Sunland Inc’s food facility registration “in the interest of public health,” following the national outbreak and a history of food safety violations reaching back over three years. “The fact that peanut butter made by the company has been linked to an outbreak … …
The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide. For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down…
The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide. For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down…
The Food and Drug Administration today shut down the country’s largest organic peanut butter processor following a salmonella outbreak that sickened scores of people nationwide. For the first time the FDA has utilized new power granted by the 2011 food safety law and shut down…
The Food and Drug Administration says it has approved the first seasonal flu vaccine made using animal cell technology, rather than the half-century egg method.
(Reuters) – A U.S. Food and Drug Administration panel voted unanimously to recommend the effectiveness of Dynavax Inc’s hepatitis B vaccine Heplisav, but raised concerns about its safety, asking for more data from studies on a wider population. The views of the panel of outside experts were based on data submitted by Dynavax that compared the safety and immunogenicity, or ability to evoke an immune response, of its Heplisav with that of an older vaccine named Engerix B by GlaxoSmithKline Plc. …